Leakage Current Testing 102 • Brief review of the Leakage Current Test • General Patient Leakage Current • Patient Auxiliary Leakage Current • Mains on Applied Park Leakage Testing • Medical Device Leakage Testing Considerations Webinar Notes Please use the Q & A utility to ask us any questions concerning the material being presented. You can find a recording of this webinar and presentation on our Webinar Archive page, www.arisafety.com/webinars/archived-webinars/ Please contact Amanda Boothe– on the chat line or email amanda.boothe@ikonixusa.com if you have any connection issues. Learning Objectives Touch Current • Touch Current • Patient Leakage • Patient Auxiliary Leakage • Mains on Applied Part Leakage . Leakage Current • Description • Network and MD IEC 60601-1 • IEC 60601-1 3rd Edition and the leakage current tests •Tests called out for in the standard Testing Examples • IEC 60601-1 discussion and reference diagrams •Leakage testing video examples Leakage Current Types Leakage Current Types • Electric current through a human body when it touches one or more accessible parts of an installation or surface of electrical equipment1 • Also called Enclosure Leakage Current. Patient Leakage Current • Current flowing from the patient connections via the patient to earth • Current originating from the unintended appearance of a voltage from an external source on the patient and flowing from the patient via the patient connections of an F-Type applied part to earth. Patient Auxiliary Current Current flowing in the patient in normal use between any patient connection and all other patient connections (and not intended to produce a physiological effect)2. Mains on Applied Part Application of mains voltage on an applied part or patient lead. 1 – IEC 60990 2nd edition: Methods of Measurement of Touch Current and Protective Conductor Current 2 – IEC 60601-1 3rd edition: Medical Electrical Equipment Patient Lead Types Patient Leads F-Type: APPLIED PART in which the PATIENT CONNECTIONS are isolated from other parts of the ME EQUIPMENT Type BF: F-TYPE APPLIED PART provide a higher degree of protection against electric shock than that provided by TYPE B APPLIED PARTS B Type: APPLIED PART that provides protection against electric shock Type CF: F-TYPE APPLIED PART provide a highest degree of protection against electric shock than that provided by TYPE BF APPLIED PARTS IEC 60601-1 3rd edition: Medical Electrical Equipment How Is It Measured? MD Leakage current is measured through a human body impedance network, also known as a Measuring Device (MD) Body Impedance MD is designed to simulate the impedance of the human body under various conditions. Normal and Single Fault Conditions Measurements taken under normal conditions. Measurements also taken under single fault conditions to simulate worst case scenarios THE MAIN QUESTION TO ASK What is the severity of electric current someone would be exposed to if they were to touch the DUT under such conditions? How Is It Measured? Medical Devices IT Equipment Electric Spas MD will vary by product standard. Most MDs are derived from IEC 60990-1 Poll Question Question Goes Here A. Answer Choice A B. Answer Choice B C. Answer Choice C D. Answer Choice D IEC 60601-1 Medical Equipment Patient Leakage Current Patient Leakage Current Touch Current 60601-1 – Figure 14 Touch Current 60601-1 – Figure 15 Video Demonstration Patient Auxiliary Current Mains on Applied Part Poll Question Question Goes Here A. Answer Choice A B. Answer Choice B C. Answer Choice C D. Answer Choice D Additional Tests and Considerations Leakage current Mains Voltage on Applied Part Figure 16 External voltage on SIO Figure 17 External voltage on metal accessible part that is not PE Figure 18 Educational Resources Visit us online to view all of our Educational Resources arisafety.com/support/educational-resources/ Contact Us You can find a recording of this webinar and presentation on our Webinar Archive page, arisafety.com/webinars/archived-webinars/ Check out our website for more information arisafety.com For any questions about our webinars send an email to Amanda at amanda.boothe@ikonixusa.com
